Emergency reversal of pentasaccharide anticoagulants: A systematic review of the literature

Transfusion Medicine

Volumn 22, Issue 2, 2012, Pages 108-115

  Elmer, J ^a   Wittels, K A ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

Blood bank; Coagulation factor replacement therapies; Haemostasis; Low molecular weight heparin

Indexed keywords

ACTIVATED PROTHROMBIN COMPLEX; ANTICOAGULANT AGENT; FONDAPARINUX; IDRAPARINUX; PENDASACCHARIDE ANTICOAGULANT; PENTASACCHARIDE; PROCOAGULANT; PROTHROMBIN COMPLEX; RECOMBINANT ACTIVATED FACTOR VIIA; UNCLASSIFIED DRUG;

ANTICOAGULANT THERAPY; ARTICLE; BLOOD CLOT LYSIS; CINAHL; COCHRANE LIBRARY; DRUG EFFICACY; EMBASE; HUMAN; MEDLINE; PARTIAL THROMBOPLASTIN TIME; PROTHROMBIN TIME; SYSTEMATIC REVIEW; THROMBIN TIME;

ANTICOAGULANTS; BLOOD COAGULATION FACTORS; FACTOR VIIA; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; MEDLINE; PROTEIN C; RECOMBINANT PROTEINS;

EID: 84858800061     PISSN: 09587578     EISSN: 13653148     Source Type: Journal    
DOI: 10.1111/j.1365-3148.2011.01125.x     Document Type: Article

References (74)

1. Abshire, T. (2008) Safety update on recombinant factor VIIa in the treatment of congenital and acquired hemophilia. Seminars in Hematology, 45, S3-S6.
2. Abshire, T. & Kenet, G. (2008) Safety update on the use of recombinant factor VIIa and the treatment of congenital and acquired deficiency of factor VIII or IX with inhibitors. Haemophilia, 14, 898-902.
3. PERSIST Investigators. (2004) A novel long-acting synthetic factor Xa inhibitor (SanOrg34006) to replace warfarin for secondary prevention in deep vein thrombosis. A phase II evaluation. Journal of Thrombosis and Haemostasis, 2, 47-53.
4. Arkel, Y.S, Paidas, M.J. et al. (2002) The use of coagulation activation markers (soluble fibrin polymer, TpP, prothrombin fragment 1·2, thrombin-antithrombin, and D-dimer) in the assessment of hypercoagulability in patients with inherited and acquired prothrombotic disorders. Blood Coagulation and Fibrinolysis, 13, 199-205.
5. Astermark, J., Donfield, S.M. et al. (2007) A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. Blood, 109, 546-551.
6. Barrowcliffe, T.W., Havercroft, S.J. et al. (1987) The effect of Ca2+, phospholipid and factor V on the anti-(factor Xa) activity of heparin and its high-affinity oligosaccharides. The Biochemical Journal, 243, 31-37.
7. Bauer, K.A., Eriksson, B.I. et al. (2001) Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. The New England Journal of Medicine, 345, 1305-1310.
8. Beguin, S., Choay, J. et al. (1989) The action of a synthetic pentasaccharide on thrombin generation in whole plasma. Thrombosis and Haemostasis, 61, 397-401.
9. Bijsterveld, N.R., Moons, A.H. et al. (2002) Ability of recombinant factor VIIa to reverse the anticoagulant effect of the pentasaccharide fondaparinux in healthy volunteers. Circulation, 106, 2550-2554.
10. Bijsterveld, N.R., Vink, R. et al. (2004) Recombinant factor VIIa reverses the anticoagulant effect of the long-acting pentasaccharide idraparinux in healthy volunteers. British Journal of Haematology, 124, 653-658.
11. Bilora, F., Boccioletti, V. et al. (2001) Hemophilia A, von Willebrand disease, and atherosclerosis of abdominal aorta and leg arteries: factor VIII and von Willebrand factor defects appear to protect abdominal aorta and leg arteries from atherosclerosis. Clinical Applied Thrombosis/Hemostasis, 7, 311-313.
12. Blauhut, B. (1999) Indications for prothrombin complex concentrates in massive transfusions. Thrombosis Research, 95, S63-S69.
13. Broze, G.J. Jr., Higuchi, D.A. (1996) Coagulation-dependent inhibition of fibrinolysis: role of carboxypeptidase-U and the premature lysis of clots from hemophilic plasma. Blood, 88, 3815-3823.
14. Buller, H.R., Davidson, B.L. et al. (2003) Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. The New England Journal of Medicine, 349, 1695-1702.
15. Buller, H.R. Cohen, A.T. et al. (2007) Extended prophylaxis of venous thromboembolism with idraparinux. The New England Journal of Medicine, 357, 1105-1112.
16. Buller, H.R., Davidson, B.L. et al. (2004) Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Annals of Internal Medicine, 140, 867-873.
17. Choay, J., Petitou, M. et al. (1983) Structure-activity relationship in heparin: a synthetic pentasaccharide with high affinity for antithrombin III and eliciting high anti-factor Xa activity. Biochemical and Biophysical Research Communication, 116, 492-499.
18. Dager, W.E., Andersen, J. et al. (2004) Special considerations with fondaparinux therapy: heparin-induced thrombocytopenia and wound healing. Pharmacotherapy, 24, 88S-94S.
19. Dargaud, Y., Beguin, S. et al. (2005) Evaluation of thrombin generating capacity in plasma from patients with haemophilia A and B. Thrombosis and Haemostasis, 93, 475-480.
20. Dargaud, Y., Trzeciak, M.C. et al. (2006) Use of calibrated automated thrombinography +/- thrombomodulin to recognise the prothrombotic phenotype. Thrombosis and Haemostasis, 96, 562-567.
21. Desmurs-Clavel, H., Huchon, C. et al. (2009) Reversal of the inhibitory effect of fondaparinux on thrombin generation by rFVIIa, aPCC and PCC. Thrombosis Research, 123, 796-798.
22. Donat, F., Duret, J.P. et al. (2002) The pharmacokinetics of fondaparinux sodium in healthy volunteers. Clinical Pharmacokinetics, 41(Suppl. 2), 1-9.
23. Dusel, C.H., Grundmann, C. et al. (2004) Identification of prothrombin as a major thrombogenic agent in prothrombin complex concentrates. Blood Coagulation and Fibrinolysis, 15, 405-411.
24. Eriksson, B.I., Bauer, K.A. et al. (2001) Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip-fracture surgery. The New England Journal of Medicine, 345, 1298-1304.
25. Fareed, J., Hoppensteadt, D.A. et al. (1998) Useful laboratory tests for studying thrombogenesis in acute cardiac syndromes. Clinical Chemistry, 44, 1845-1853.
26. Gatt, A., van Veen, J.J. et al. (2008) Thrombin generation assays are superior to traditional tests in assessing anticoagulation reversal in vitro. Thrombosis and Haemostasis, 100, 350-355.
27. Gerotziafas, G.T., Zervas, K. et al. (2002) On the mechanism of action of recombinant activated factor VII administered to patients with severe thrombocytopenia and life-threatening haemorrhage: focus on prothrombin activation. British Journal of Haematology, 117, 705-708.
28. Gerotziafas, G.T., Depasse, F. et al. (2004a) Recombinant factor VIIa partially reverses the inhibitory effect of fondaparinux on thrombin generation after tissue factor activation in platelet rich plasma and whole blood. Thrombosis and Haemostasis, 91, 531-537.
29. Gerotziafas, G.T., Depasse, F. et al. (2004b) Comparison of the effect of fondaparinux and enoxaparin on thrombin generation during in-vitro clotting of whole blood and platelet-rich plasma. Blood Coagulation and Fibrinolysis, 15, 149-156.
30. Groce, J.B. III. (2001) Treatment of deep vein thrombosis using low-molecular-weight heparins. The American Journal of Managed Care, 7, S510-515; discussion S515-S523.
31. Guyatt, G. (2008) Users' Guides to the Medical Literature: Essentials of Evidence-Based Clinical Practice. McGraw-Hill Medical, New York.
32. Hellstern, P., Beeck, H. et al. (1997) Factor VII and activated-factor-VII content of prothrombin complex concentrates. The PCC Study Group. Vox Sanguinis, 73, 155-161.
33. Hellstern, P., Halbmayer, W.M. et al. (1999) Prothrombin complex concentrates: indications, contraindications, and risks: a task force summary. Thrombosis Research, 95, S3-S6.
34. Hemker, H.C., Wielders, S. et al. (1993) Continuous registration of thrombin generation in plasma, its use for the determination of the thrombin potential. Thrombosis and Haemostasis, 70, 617-624.
35. Hemker, H.C., Giesen, P.L. et al. (2000) The thrombogram: monitoring thrombin generation in platelet-rich plasma. Thrombosis and Haemostasis, 83, 589-591.
36. Huvers, F., Slappendel, R. et al. (2005) Treatment of postoperative bleeding after fondaparinux with rFVIIa and tranexamic acid. The Netherlands Journal of Medicine, 63, 184-186.
37. Iorio, A., Matino, D. et al. (2010) Recombinant factor VIIa concentrate versus plasma derived concentrates for the treatment of acute bleeding episodes in people with haemophilia and inhibitors. Cochrane Database System Review, 8, CD004449.
38. Kjalke, M., Ezban, M. et al. (2001) High-dose factor VIIa increases initial thrombin generation and mediates faster platelet activation in thrombocytopenia-like conditions in a cell-based model system. British Journal of Haematology, 114, 114-120.
39. Klement, P., Liao, P. et al. (1999) A novel approach to arterial thrombolysis. Blood, 94, 2735-2743.
40. Kohler, M. (1999) Thrombogenicity of prothrombin complex concentrates. Thrombosis Research, 95, S13-S17.
41. Lassen, M.R., Bauer, K.A. et al. (2002) Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomised double-blind comparison. Lancet, 359, 1715-1720.
42. Liberati, A., Altman, D.G. et al. (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. British Medical Journal, 339, b2700.
43. Lisman, T., De Groot, P.G. (2003) Rebuttal to: effect of heparin on TAFI-dependent inhibition of fibrinolysis. Journal of Thrombosis and Haemostasis, 1, 200-201; author reply 202.
44. Lisman, T., Leebeek, F.W. et al. (2001) Thrombin-activatable fibrinolysis inhibitor deficiency in cirrhosis is not associated with increased plasma fibrinolysis. Gastroenterology, 121, 131-139.
45. Lisman, T., Adelmeijer, J. et al. (2003a) Enhancement of fibrinolytic potential in vitro by anticoagulant drugs targeting activated factor X, but not by those inhibiting thrombin or tissue factor. Blood Coagulation and Fibrinolysis, 14, 557-562.
46. Lisman, T., Bijsterveld, N.R. et al. (2003b) Recombinant factor VIIa reverses the in vitro and ex vivo anticoagulant and profibrinolytic effects of fondaparinux. Journal of Thrombosis and Haemostasis, 1, 2368-2373.
47. Meddahi, S., Bara, L. et al. (2000) Pharmacologic modulation of thrombin generation associated with human clots by human purified antithrombin alone or in the presence of low molecular weight heparin or unfractionated heparin. Blood Coagulation and Fibrinolysis, 11, 51-59.
48. Nagashima, M., Werner, M. et al. (2000) An inhibitor of activated thrombin-activatable fibrinolysis inhibitor potentiates tissue-type plasminogen activator-induced thrombolysis in a rabbit jugular vein thrombolysis model. Thrombosis Research, 98, 333-342.
49. Perzborn, E., Strassburger, J. et al. (2005) In vitro and in vivo studies of the novel antithrombotic agent BAY 59-7939 - an oral, direct factor Xa inhibitor. Journal of Thrombosis and Haemostasis, 3, 514-521.
50. Philippou, H., Adami, A. et al. (1996) High purity factor IX and prothrombin complex concentrate (PCC): pharmacokinetics and evidence that factor IXa is the thrombogenic trigger in PCC. Thrombosis and Haemostasis, 76, 23-28.
51. Pieters, J., Willems, G. et al. (1988) Inhibition of factor IXa and factor Xa by antithrombin III/heparin during factor X activation. Journal of Biological Chemistry, 263, 15313-15318.
52. Puetz, J. (2010) Optimal use of recombinant factor VIIa in the control of bleeding episodes in hemophilic patients. Journal of Drug Design Development and Therapy, 4, 127-137.
53. Regnault, V., Hemker, H.C. et al. (2004) Phenotyping the haemostatic system by thrombography - potential for the estimation of thrombotic risk. Thrombosis Research, 114, 539-545.
54. Rezaie, A.R. (2001) Prothrombin protects factor Xa in the prothrombinase complex from inhibition by the heparin-antithrombin complex. Blood, 97, 2308-2313.
55. Roberts, H.R., Monroe, D.M. et al. (2004) The use of recombinant factor VIIa in the treatment of bleeding disorders. Blood, 104, 3858-3864.
56. Robinson, D.M., Wellington, K. (2005) Fondaparinux sodium: a review of its use in the treatment of acute venous thromboembolism. American Journal of Cardiovascular Drugs, 5, 335-346.
57. Rosenberg, R.D. (2001) Redesigning heparin. The New England Journal of Medicine, 344, 673-675.
58. Rosing, J., Tans, G. et al. (1997) Oral contraceptives and venous thrombosis: different sensitivities to activated protein C in women using second- and third-generation oral contraceptives. British Journal of Haematology, 97, 233-238.
59. Salooja, N., Perry, D.J. (2001) Thrombelastography. Blood Coagulation and Fibrinolysis, 12, 327-337.
60. Samama, C.M. (2008) Prothrombin complex concentrates: a brief review. European Journal of Anaesthesiology, 25, 784-789.
61. Shore-Lesserson, L. (2005) Evidence based coagulation monitors: heparin monitoring, thromboelastography, and platelet function. Seminars in Cardiothoracic and Vascular Anesthesia, 9, 41-52.
62. Takeyama, M., Sakurai, Y. et al. (2007) Heparin-induced inhibitory effects of a prothrombin complex concentrate on global tests of haemostasis. Blood Coagulation and Fibrinolysis, 18, 1-7.
63. Tan, K.T., Lip, G.Y. (2005) Fondaparinux. Current Pharmaceutical Design, 11, 415-419.
64. The Rembrandt Investigators. (2000) Treatment of proximal deep vein thrombosis with a novel synthetic compound (SR90107A/ORG31540) with pure anti-factor Xa activity: a phase II evaluation. Circulation, 102, 2726-2731.
65. Toschi, V., Gallo, R. et al. (1997) Tissue factor modulates the thrombogenicity of human atherosclerotic plaques. Circulation, 95, 594-599.
66. Treur, M.J., McCracken, F. et al. (2009) Efficacy of recombinant activated factor VII vs. activated prothrombin complex concentrate for patients suffering from haemophilia complicated with inhibitors: a Bayesian meta-regression. Haemophilia, 15, 420-436.
67. Turpie, A.G., Bauer, K.A. et al. (2002) Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. Archives of Internal Medicine, 162, 1833-1840.
68. von dem Borne, P.A., Meijers, J.C. et al. (1995) Feedback activation of factor XI by thrombin in plasma results in additional formation of thrombin that protects fibrin clots from fibrinolysis. Blood, 86, 3035-3042.
69. Walenga, J.M., Petitou, M. et al. (1987) Antithrombotic activity of a synthetic heparin pentasaccharide in a rabbit stasis thrombosis model using different thrombogenic challenges. Thrombosis Research, 46, 187-198.
70. Warkentin, T.E., Crowther, M.A. (2002) Reversing anticoagulants both old and new. Canadian Journal of Anaesthesia, 49, S11-S25.
71. Weitz, J.I. (2004) New anticoagulants for treatment of venous thromboembolism. Circulation, 110, I19-I26.
72. Wilde, J.T. (2002) Evidence for the use of activated prothrombin complex concentrates (aPCCs) in the treatment of patients with haemophilia and inhibitors. Pathophysiology of Haemostasis and Thrombosis, 32(Suppl. 1), 9-12.
73. Wyer, P.C., Rowe, B.H. et al. (2000) Evidence-based emergency medicine. The clinician and the medical literature: when can we take a shortcut? Annals of Emergency Medicine, 36, 149-155.
74. Young, G., Yonekawa, K.E. et al. (2007) Recombinant activated factor VII effectively reverses the anticoagulant effects of heparin, enoxaparin, fondaparinux, argatroban, and bivalirudin ex vivo as measured using thromboelastography. Blood Coagulation and Fibrinolysis, 18, 547-553.